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A Pharmacist’s Guide to IntermezzoIntermezzo® (zolpidem
tartrate) is indicated for use as needed for the treatment of
insomnia when a middle-of-the-night awakening is followed by
difficulty returning to sleep.
Limitations of Use: Intermezzo is not indicated for the
treatment of middle-of-the-night insomnia when the patient has
fewer than 4 hours of bedtime remaining before the planned time of
waking.
Important Safety Information• Intermezzo is contraindicated in
patients with known hypersensitivity to zolpidem.
Observed reactions with zolpidem include anaphylaxis and
angioedema.
FAST ASLEEP. AWAKE IN THE MIDDLE OF THE NIGHT.
BACK TO SLEEP WITH INTERMEZZO.
Please read accompanying Full Prescribing Information.
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Intermezzo® (zolpidem tartrate) is indicated for use as needed
for the treatment of insomnia when a middle-of-the-night awakening
is followed by difficulty returning to sleep. Limitations of Use:
Intermezzo is not indicated for the treatment of
middle-of-the-night insomnia when the patient has fewer than 4
hours of bedtime remaining before the planned time of waking.
Why dispense Intermezzo as prescribed?
3 Key points a pharmacist should know
1 There is no AB rated generic equivalent for the two available
doses of Intermezzo—1.75 mg and 3.5 mg
2 Intermezzo is the first and only prescription sleep aid
approved for use as needed for the treatment of insomnia when a
middle-of-the-night awakening is followed by difficulty returning
to sleep with at least 4 hours left for sleep
3 Intermezzo has been studied in patients with
middle-of-the-night insomnia
There is no AB rated equivalent for the two available doses of
Intermezzo (1.75 mg and 3.5 mg). No other prescription sleep aid
should be substituted for Intermezzo.
Important Safety Information• Co-administration with Intermezzo
and other CNS depressants increases the risk of CNS
depression. Intermezzo should not be taken with alcohol. The use
of Intermezzo with other sedative-hypnotics (including other
zolpidem products) at bedtime or the middle of the night is not
recommended.
• The risk of next-day driving impairment (and psychomotor
impairment) is increased if Intermezzo is taken with less than 4
hours of bedtime remaining; if higher than recommended dose is
taken; if co-administered with other CNS depressants; or
co-administered with other drugs that increase the blood levels of
zolpidem. A small negative effect on SDLP (standard deviation of
lateral position, a measure of driving impairment) may remain in
some patients 4 hours after taking Intermezzo, such that a
potential negative effect on driving cannot be completely
excluded.
Please read accompanying Full Prescribing Information.
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Intermezzo is the first and only prescription sleep aid approved
for once-nightly, as-needed dosing for middle-of-the-night
awakenings if your patient has at least 4 hours of sleep
leftDiscuss the following important administration instructions
with your patients when providing them with Intermezzo® (zolpidem
tartrate). Remind them to read the Instructions for Use section in
the Medication Guide for detailed instructions on how to take
Intermezzo.
Dosage and administration Important administration
instructions
• Intermezzo is to be taken in bed when a patient wakes in the
middle of the night and has difficulty returning to sleep
• Intermezzo should only be taken if the patient has at least 4
hours of bedtime remaining before the planned time of waking
• Intermezzo should be placed under the tongue and allowed to
disintegrate completely before swallowing
• The tablet should not be swallowed whole
• For optimal effect, Intermezzo should not be administered with
or immediately after a meal
• The blister should be removed from the pouch just prior to
dosing
• Intermezzo should not be taken if alcohol was consumed that
day or before bed
Recommended dosing• The recommended and maximum dose of
Intermezzo is 1.75 mg for women and 3.5 mg for
men, taken only once per night as needed if a
middle-of-the-night awakening is followed by difficulty returning
to sleep. The recommended doses for women and men are different
because women clear zolpidem from the body at a lower rate than
men
• The recommended Intermezzo dose for men and women who are
taking concomitant CNS depressants is 1.75 mg
• Dose adjustment of concomitant CNS depressants may be
necessary when co-administered with Intermezzo because of
potentially additive effects
• The use of Intermezzo with other sedative-hypnotics (including
other zolpidem products) at bedtime or the middle of the night is
not recommended
• Geriatric patients may be especially sensitive to the effects
of zolpidem
• The recommended dose of Intermezzo in men and women over 65
years old and patients with hepatic impairment is 1.75 mg, taken
only once per night if needed
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Please read accompanying Full Prescribing Information.
Important information to review with patientsInform patients and
their families about the benefits and risks of treatment with
Intermezzo. Inform patients of the availability of a Medication
Guide and instruct them to read the Medication Guide prior to
initiating treatment with Intermezzo and with each prescription
refill. Review the Intermezzo Medication Guide with every patient
prior to initiation of treatment. Instruct patients or caregivers
that Intermezzo should be taken only as prescribed.
CNS depressant effects and next-day impairment• Tell patients
that Intermezzo has the potential to cause next-day impairment, and
that this
risk is increased if dosing instructions are not carefully
followed
• Tell patients to wait for at least 4 hours after dosing and
until they feel fully awake before driving or engaging in other
activities requiring full mental alertness
Severe anaphylactic and anaphylactoid reactions• Inform patients
that severe anaphylactic and anaphylactoid reactions have
occurred
with zolpidem
• Describe the signs/symptoms of these reactions and advise
patients to seek medical attention immediately if any of them
occur
Sleep-driving and other complex behaviors• Instruct patients to
inform their families that zolpidem has been associated with
“sleep-driving”
and other complex behaviors while not being fully awake
(preparing and eating food, making phone calls, or having sex)
• Tell patients and their families to call their healthcare
providers immediately if they develop any of these symptoms
Suicide• Tell patients to immediately report any suicidal
thoughts to their healthcare provider
Important Safety Information• The failure of insomnia to remit
after 7 to 10 days of treatment may indicate the presence
of a primary psychiatric and/or medical illness that should be
evaluated.
• Cases of angioedema involving the tongue, glottis, or larynx
have been reported in patients after taking the first or subsequent
doses of zolpidem. Some patients have had additional symptoms such
as dyspnea, throat closing, or nausea and vomiting that suggest
anaphylaxis. Some patients have required medical therapy in the
emergency department. Angioedema, and additional symptoms
suggesting anaphylaxis, may occur in patients taking zolpidem and
may be fatal. Patients who develop angioedema or anaphylaxis should
not be rechallenged.
Intermezzo® (zolpidem tartrate) is indicated for use as needed
for the treatment of insomnia when a middle-of-the-night awakening
is followed by difficulty returning to sleep. Limitations of Use:
Intermezzo is not indicated for the treatment of
middle-of-the-night insomnia when the patient has fewer than 4
hours of bedtime remaining before the planned time of waking.
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Help patients save with IntermezzoPatients can get a free 3-day
trial with a valid 3-tablet prescription for Intermezzo AND they
may be eligible to save up to $45 on their prescriptions for
Intermezzo with the Savings Card.
Free 3-day trial of Intermezzo
• The Intermezzo Trial Offer allows all patients with a valid
3-tablet prescription for Intermezzo to receive a 3-day trial of
Intermezzo at no cost
• There is a limit of one Trial Offer per patient and the card
expires 3/31/2013
• Patients must meet the Terms and Conditions
Intermezzo Savings Card
• The patient is responsible for the first $15 and any amount
that exceeds the total Intermezzo Patient Savings Card offer
• Only valid for prescriptions written for a minimum of 20
tablets
• Medicare/Medicaid patients and patients insured by federal or
state government programs are not eligible to use this Savings
Card
• A valid prescription must accompany each Intermezzo Savings
Card at time of first use
• Patients can use their Intermezzo Savings Card every 28 days
until the offer expires on 3/31/2013
• Patients must meet the Eligibility Requirements and Terms and
Conditions
To learn more about the Intermezzo Savings Card and Free Trial
Offer, scan this code with your smartphone or visit
IntermezzoRX.com
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Important Safety Information
• Abnormal thinking and behavior changes have been reported in
patients treated with a sedative-hypnotic including zolpidem.
Complex behaviors, including driving or eating while not fully
awake, with amnesia for the event, as well as visual and auditory
hallucinations and abnormal behaviors such as decreased inhibition,
bizarre behavior, agitation, and depersonalization may occur.
Although behaviors such as “sleep-driving” have occurred with
zolpidem alone at therapeutic doses, the co-administration of
zolpidem with alcohol and other CNS depressants increases the risk
of such behaviors, as does the use of zolpidem at doses exceeding
the maximum recommended dose. Discontinuation of Intermezzo should
be strongly considered for patients reporting a “sleep-driving”
episode.
• In primarily depressed patients, worsening of depression,
including suicidal thoughts and actions (including completed
suicides) have been reported with the use of sedative-hypnotics.
Intentional overdosage is more common in this group of patients;
therefore, protective measures may be required and prescribe the
least amount of Intermezzo that is feasible.
• Because persons with a history of addiction to or abuse of
drugs or alcohol are at increased risk for misuse, abuse, and
addiction of zolpidem, they should be monitored carefully when
receiving Intermezzo. Zolpidem tartrate is a Schedule IV controlled
substance. Post-marketing reports of abuse, dependence, and
withdrawal resulting from use of oral zolpidem tartrate have been
received. Zolpidem has produced withdrawal signs and symptoms
following a rapid dose decrease or abrupt discontinuation.
• The most commonly observed adverse reactions (>1%) were
headache (Intermezzo 3%, placebo 1%), nausea (1% for both patient
groups), and fatigue (Intermezzo 1%, placebo 0%).
Please read accompanying Full Prescribing Information.
©2012 Purdue Pharma L.P., Stamford, CT 06901-3431 A8521-1 INT147
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Intermezzo® (zolpidem tartrate) is indicated for use as needed
for the treatment of insomnia when a middle-of-the-night awakening
is followed by difficulty returning to sleep. Limitations of Use:
Intermezzo is not indicated for the treatment of
middle-of-the-night insomnia when the patient has fewer than 4
hours of bedtime remaining before the planned time of waking.